A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00718380
First received: July 16, 2008
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.


Condition Intervention Phase
Solid Tumor
Drug: ABT-869
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety tolerability assessment [ Time Frame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity determination [ Time Frame: Weekly assessment for the first 3 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile evaluation [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preliminary tumor response [ Time Frame: Every 6 week ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
Drug: ABT-869
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Other Name: ABT-869
Experimental: Group 2
Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
Drug: ABT-869
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Other Name: ABT-869
Experimental: Group 3
Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
Drug: ABT-869
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Other Name: ABT-869
Experimental: Group 4
Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3
Drug: ABT-869
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Other Name: ABT-869

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
  • Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
  • The subject must have adequate bone marrow, renal and hepatic function.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
  • The subject must voluntarily sign and date an informed consent.

Exclusion Criteria

  • The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
  • The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
  • The subject with the following conditions during screening assessment.

    1. proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
    2. diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
    3. a history of or currently exhibits clinically significant cancer related events of bleeding
    4. LV Ejection Fraction < 50%
    5. received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
    6. receiving therapeutic anticoagulation therapy
    7. having fractures except for chronic bone lesion due to bone metastases
  • The subject exhibits evidence of other clinically significant uncontrolled condition(s).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718380

Locations
Japan
Site Reference ID/Investigator# 6891
Tokyo, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Susumu Matsuki, BS Abbott Japan Co.,Ltd
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00718380     History of Changes
Other Study ID Numbers: M10-227
Study First Received: July 16, 2008
Last Updated: July 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014